Back to resultsFalls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility (CFC)
Primary Purpose
Accidental Falls, Fractures
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
gait and cognitive assessments
blood sample
osteodensitometry
Sponsored by
About this trial
This is an interventional basic science trial for Accidental Falls focused on measuring middle-aged and aged adults, fall in the previous year
Eligibility Criteria
Inclusion Criteria:
- Affiliation to the social security system
- For subjects with fracture : victim of a low-energy fracture of the upper or lower limb that was consecutive to a fall from standing height, and who has accepted to realize a DXA exam in the context of the medical follow-up
- For control subjects : victim of a fall from standing height, with no fracture, matched in terms of age, sex, socio-cultural level and living space with subjects with fracture.
- Written informed consent
Exclusion Criteria:
- Subject who is deprived of liberty, under supervision or legal guardianship
- Pathology affecting balance (Parkinson's disease, after-effects of stroke, …)
- Important visual impairment : age-related macular degeneration, …
- Depressed state
- Important consumption of alcohol (> 14 drinks per week for women / >21 for men)
- Subject who is concurrently participating in another clinical study (unless prior notice of the principal investigator)
- Fall has been caused by a third party (e.g. : pushing), is not from standing height (e.g. : fall from a ladder); fracture is not a low-energy one (e.g. : further a fall during running)
For subjects with fracture :
- The fracture is not consecutive to a fall
- The fracture is pathological, beyond osteoporosis (e.g. : bone metastases)
- The last fall responsible for a fracture goes back more than 6 months
For control subjects :
o The fall goes back more than 12 months
- The fall has led to a medical consultation
Sites / Locations
- University Hospital
- Dr Alain Daragon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Fall with fracture
controls
Arm Description
Fall with fracture in the last 6 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry
Fall without fracture in the last 12 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry
Outcomes
Primary Outcome Measures
Analysis of a global cognitive efficiency score Analysis of bone mineral density
MMS, MoCA
Secondary Outcome Measures
Age
Cognitive scores
Mainly tests of memory, attention and executive functions
Fracture features
Location and severity
Balance and walking parameters
Tinetti scale, TUG and dual-tasks
handgrip force
using a dynamometer
Daily life scales scores
Mainly IADL
fear of falling
ABC-scale
functional restrictions score
Lequesne score
Degree of depression
MADRS
biological data
25OHD
Dual-energy X-ray absorptiometry
bone mineral densitometry
Full Information
NCT ID
NCT02292316
First Posted
September 26, 2014
Last Updated
March 2, 2020
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT02292316
Brief Title
Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility
Acronym
CFC
Official Title
Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2011 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether cognitive disorders are a risk factor for a fracture after a fall independently of a bone fragility.
Detailed Description
The fall is a major problem in the elderly. After 65 year old, falls represent 84% of daily living accidents and almost half of the post fall injuries are fractures (Ricard and Thélot, 2007). These falls with fracture lead to a loss of autonomy and a high health cost. Their prevention is a crucial focus of research.
Even if it is obvious that subjects with osteoporosis have a higher risk of fracture than those with a normal bone mineral density, recent studies have shown that most victims of fracture post-fall do not comply with the densitometric definition of osteoporosis.
It is well established that the presence of cognitive disorders, frequent in the elderly, is an important risk factor for falls; It might also be a risk factor for fracture after a fall with an unadapted postural or balance control.
The investigators will test this hypothesis on 150 victims of fracture (upper or lower limb) consecutive to a fall from standing height, recruited in the hospitals of Caen and Rouen (France) in the context of their medical follow-up (with blood and dual energy x-ray absorptiometry [DXA] exams). These patients will be matched to 150 control participants (victims of a fall with no fracture, submitted to the same exams).
All the participants are subjects to an in-depth study of cognitive functions, postural and walking tests and to various scales (daily life activities, depression, ...).
These exams will take half a day, with a two-year follow up (in which the participant will have to note new falls and new medical treatments)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls, Fractures
Keywords
middle-aged and aged adults, fall in the previous year
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fall with fracture
Arm Type
Experimental
Arm Description
Fall with fracture in the last 6 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry
Arm Title
controls
Arm Type
Sham Comparator
Arm Description
Fall without fracture in the last 12 months; Interventions : behavioral, biological and other; Behavioral intervention includes gait and cognitive assessments Blood sample Osteodensitometry
Intervention Type
Behavioral
Intervention Name(s)
gait and cognitive assessments
Intervention Description
several tests are given in each domain
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
routine analyses in rheumatology such blood count and 25OH-D
Intervention Type
Other
Intervention Name(s)
osteodensitometry
Intervention Description
Looking for osteoporosis
Primary Outcome Measure Information:
Title
Analysis of a global cognitive efficiency score Analysis of bone mineral density
Description
MMS, MoCA
Time Frame
on the inclusion day and two years after
Secondary Outcome Measure Information:
Title
Age
Time Frame
on the inclusion day and over two years
Title
Cognitive scores
Description
Mainly tests of memory, attention and executive functions
Time Frame
on the inclusion day and over two years
Title
Fracture features
Description
Location and severity
Time Frame
on the inclusion day and over two years
Title
Balance and walking parameters
Description
Tinetti scale, TUG and dual-tasks
Time Frame
on the inclusion day and over two years
Title
handgrip force
Description
using a dynamometer
Time Frame
on the inclusion day and over two years
Title
Daily life scales scores
Description
Mainly IADL
Time Frame
on the inclusion day and over two years
Title
fear of falling
Description
ABC-scale
Time Frame
on the inclusion day and over two years
Title
functional restrictions score
Description
Lequesne score
Time Frame
on the inclusion day and over two years
Title
Degree of depression
Description
MADRS
Time Frame
on the inclusion day and over two years
Title
biological data
Description
25OHD
Time Frame
on the inclusion day and over two years
Title
Dual-energy X-ray absorptiometry
Description
bone mineral densitometry
Time Frame
on the inclusion day and two years after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Affiliation to the social security system
For subjects with fracture : victim of a low-energy fracture of the upper or lower limb that was consecutive to a fall from standing height, and who has accepted to realize a DXA exam in the context of the medical follow-up
For control subjects : victim of a fall from standing height, with no fracture, matched in terms of age, sex, socio-cultural level and living space with subjects with fracture.
Written informed consent
Exclusion Criteria:
Subject who is deprived of liberty, under supervision or legal guardianship
Pathology affecting balance (Parkinson's disease, after-effects of stroke, …)
Important visual impairment : age-related macular degeneration, …
Depressed state
Important consumption of alcohol (> 14 drinks per week for women / >21 for men)
Subject who is concurrently participating in another clinical study (unless prior notice of the principal investigator)
Fall has been caused by a third party (e.g. : pushing), is not from standing height (e.g. : fall from a ladder); fracture is not a low-energy one (e.g. : further a fall during running)
For subjects with fracture :
The fracture is not consecutive to a fall
The fracture is pathological, beyond osteoporosis (e.g. : bone metastases)
The last fall responsible for a fracture goes back more than 6 months
For control subjects :
o The fall goes back more than 12 months
The fall has led to a medical consultation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Marcelli, Professor
Organizational Affiliation
CHU of Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Dr Alain Daragon
City
Rouen
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29974390
Citation
Langeard A, Pothier K, Chastan N, Marcelli C, Chavoix C, Bessot N. Reduced gait and postural stability under challenging conditions in fallers with upper limb fracture. Aging Clin Exp Res. 2019 Apr;31(4):483-489. doi: 10.1007/s40520-018-0992-z. Epub 2018 Jul 4.
Results Reference
derived
PubMed Identifier
27630572
Citation
Langeard A, Pothier K, Morello R, Lelong-Boulouard V, Lescure P, Bocca ML, Marcelli C, Descatoire P, Chavoix C. Polypharmacy Cut-Off for Gait and Cognitive Impairments. Front Pharmacol. 2016 Aug 31;7:296. doi: 10.3389/fphar.2016.00296. eCollection 2016.
Results Reference
derived
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Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility
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